Principles: Cord blood is defined as blood
contained within the umbilical cord and blood in the contiguous
placental circulation. Collection of cord blood for the express
purpose of harvesting stem cells should be performed in a manner
which would not alter the delivery of the infant; would not
increase the likelihood of any adverse reaction in the infant or
mother; and/or would not preclude appropriate medical management
of the infant or mother, including collection of cord blood
diagnostic specimens.

I. Donor evaluation

A. Informed consent.

Informed consent for collection of cord blood must,
in all cases, be obtained before stem cells are placed in
inventory. Consent from preferably both parents, but at least one
parent or a legal guardian, should be obtained. Parents should be
clearly informed of all available options. The informed consent
document should disclose all financial ramifications of the
collection and storage procedure, and include a statement
regarding limitations of any implied guarantees or
warranties.

1. Timing of informed consent.
Whenever possible, informed consent should be obtained prior to
onset of labor. In all cases of in utero collection,
consent must be obtained prior to
collection.

2. Person obtaining informed
consent. Informed consent should be obtained by an
individual appropriately trained in the informed consent process,
and with sufficient knowledge of all aspects of cord blood
collection, processing and storage, as well as relevant
applications of the stem cell product.

1. A personal and family medical history of the
biologic mother, in all cases, and biologic father, if available,
of the prospective cord blood cell donor should be obtained and
documented prior to, or within 48 hours of, the collection and
shall be reviewed prior to the release for infusion of the cord
blood-derived cells. At the time of collection, the mother should
be in good health and without evidence of active infection that
may be transmissible transplacentally. The medical history should
include an assessment of genetic disorders affecting, as a
minimum, the genetic mother, father and siblings of the
newborn.

2. A sample of blood from the donor's mother
must be collected within 30 days prior to or 72 hours after
donation and tested promptly for anti-HIV-1, anti-HIV-2,
anti-HTLV-I/II, HBsAg, anti-HBc, anti-HCV and syphilis.
Appropriate testing should be performed to demonstrate whether
the mother has active CMV infection. If the original testing was
prior to the onset of labor, it may be desirable to retest the
mother at the time of collection to minimize the window period of
any carried viral infection.

3. In the event of a positive test result for any
infectious disease (other than CMV), an attempt should be made to
notify the mother of the donor within five working days of the
receipt of the test results by the cord blood bank. Failure to
make contact with the mother for purposes of notification should
not preclude the use of the cord blood for transplant. Rather,
the nature of the infectious disease should determine the utility
of the product. It is recommended that cord blood collected from
a newborn infant whose mother has positive test results for
infectious disease markers (other than for CMV) not be used for
transplantation without documentation of the rationale for such
use from the transplant physician and the informed consent of the
patient (recipient) and/or the patient's (recipient's)
guardian. If the mother is HIV positive, cord blood should not be
used for allogeneic transplant.

4. Consideration should be given to testing a
sample of the cord blood for infectious diseases. Such a strategy
may serve as an added safeguard to ensure the identity of the
cord blood.

5. Red blood cells from the infant donor or from
the cord blood collected should be tested for ABO and Rh
group.

6. For community cord blood collections,
appropriate Class I and Class II HLA typing of the cord blood
component should be performed shortly after collection and the
results stored in a way that lends itself to search. Such storage
of data and data retrieval should be performed in accordance with
currently accepted methods. For family storage, a sample may be
held in storage for subsequent HLA typing.

C. Facility notification and authorization.
An access agreement/acknowledgment between the administration of
the hospital or collection site and the licensed cord blood bank
should be established prior to the collection of cord blood. Such
established agreement/acknowledgment should delineate
responsibilities for the collection, handling, transportation and
disposition of all cord blood samples.

II. Cord blood collection and processing methods and
procedures.

A. Cord blood collection personnel.

1. Cord blood collection should be performed by
staff with documented appropriate training, experience, and
proficiency in the technique utilized. Health professionals with
experience in venipuncture, infection control, and handling of
biohazardous material (e.g. physicians, nurses, licensed
midwives or bone marrow technicians) should receive training
sufficient to perform the procedure. Other health professional
staff will require additional training.

a. Training.

1) Standard operating procedures should be read and
understood; this should be attested to by a signed statement of
the staff.

2) Instruction may be in person or by videotape
and/or written materials.

3) Training should be acquired in advance of the
collection (preferably prior to the onset of labor).

b. Experience and proficiency.

Experience may be acquired by collection of cord
blood that is not intended for subsequent clinical use. For
personnel other than licensed health care professionals who
perform deliveries of infants, proficiency should be demonstrated
by performing a minimum of five collection procedures in which
cord blood is not intended for clinical use unless there is
documented direct supervision by trained personnel. Proficiency
should be demonstrated prior to the collection of cord blood for
clinical use, and at least yearly thereafter.

1. Procedures used should be documented to result
in retention of adequate sterility and stem cell viability.

2. The collection of cord blood should not result
in any deviation from normal obstetric procedures (e.g.
for time of clamping).

3. In utero (prior to placental delivery)
and ex utero (following placental delivery) collection
methods are both acceptable and have comparable efficacy. Use of
a closed or semi-closed system (bag or syringe) by venipuncture
of the umbilical vein under aseptic conditions is recommended.
Use of open cord vessels for collection is unacceptable.

a. The collection procedure should present no
foreseeable harm for either the mother or child or compromise the
cord blood sample.

b. In utero collection is an invasive
procedure and should be performed by the obstetrician or allied
health care professional responsible for delivery of the infant,
with full consideration of possible adverse effects on the mother
and child.

4. Collection. The collection of
cord blood should not affect the care of the mother or child and
there should be no significant deviation from normal procedures.
Collections of cord blood are generally more successful if
initiated within ten minutes of the birth of the infant.

5. Labeling of cord blood. At the
completion of collection, the primary collection container should
bear, at a minimum, sufficient information to identify the
product, the source and destination, the donor and recipient (if
known), recommended conditions for storage and transportation,
and product characteristics such as anticoagulant used.

C. Processing and storage methods. Processing
of cord blood should commence within 48 hours of collection.
Pre-processing cord blood storage temperature should be
maintained at between one degree Celsius and ambient temperature,
depending on methods used.

1. Collection and storage vessels.
Cord blood should be collected and stored in vials, bags, or
other containers approved for cryopreservation of hematopoietic
progenitor cells or validated by the cord blood bank to maintain
viability.

2. Separation methods. Separation
methods should be approved by the director, described in written
procedures and demonstrated to be free of bacterial
contamination. Methods should also be approved by the
institutional review board or be well-described in the medical
literature.

3. Sterility testing. Sterility
testing for bacterial and fungal contamination should be
performed on a sample collected after addition of the
cryoprotectant mixture and the results evaluated as a component
of quality control for the procedure. Testing may also be
performed on a sample of the cord blood obtained at the time of
collection.

4. Cryopreservation. Cells should
be cryopreserved by methods detailed in written procedures using
reagents approved for human use. Methods should be well described
in the medical literature or approved by an institutional review
board. Non-human animal colloids should not be used.

5. Storage temperature. After
processing, cells should be stored within a temperature range of
minus 196 degrees Celsius to minus 80 degrees Celsius. If the
storage period exceeds one year, cells should be stored at a
temperature of less than minus 130 degrees Celsius.

Cells should be stored continuously in either a
mechanical freezer or liquid nitrogen tank equipped with an
audible alarm.

Refrigeration devices used should be reserved for
hematopoietic progenitor cells, other tissues intended for
transplantation, and/or blood intended for transfusion. A backup
system should be in place in the event of unexpected mechanical
failure or liquid nitrogen loss.

6. Labeling. The final product
container should be labeled and/or tagged in accordance with
Department of Health regulations for labeling hematopoietic
progenitor cells found in 10 NYCRR Section 58-5.6(d)(4). The
label should be legible and indelible and, at a minimum, should
contain the donor's identification code and, if positive for
any required tests for infectious disease markers (other than
tests for CMV), a biohazard label.

7. Safeguards to prevent mixups.
The director should be responsible for implementing safeguards to
prevent mixup of specimens during collection and processing.

1. Two or more samples of cord blood should be
retained from each donor in order to provide adequate material
for confirmatory testing, additional HLA typing, and for other
additional testing (other than genetic testing) that is currently
not standard practice, but may become important as the field
matures and more information is known about in vitro
characteristics affecting component transplantability. It may
also be desirable to save similar samples from the mother's
blood.

2. It is recommended that cellular samples be
either physically stored with the actual component from which
derived or under similar conditions. A system should be in place
to ensure that the contents of the sample tube are actually
derived from the cord blood product they intend to represent.
Such assurance should be reflected in the standard operating
procedures for preparation of cellular samples, labeling of
sample tubes and storage containers, and for process control.

3. For all products still in storage or already
transplanted, samples should be retained for an appropriate
period of time. For discarded cord blood and for specimens used
for research, samples need not be retained indefinitely and may
be discarded at the time the cord blood is removed from
inventory.

E. Length of storage.

1. There is no evidence at present that cells
stored at minus 196 degrees Celsius in an undisturbed manner lose
either in vitro-determined viability or biological
activity. Therefore, at the current time, no expiration date need
be assigned to cord blood stored continuously under liquid
nitrogen.

2. For specimens whose storage may have been
compromised, assessment of the accepted in vitro
correlates for transplantability should be performed on similarly
stored samples of the product prior to ablative therapy of the
prospective patient. Such analyses may include colony growth
assays, CD34 enumeration, viability testing, or other appropriate
indices of viability acceptable to the transplant physician.
Appropriate microbiologic assays should be performed. Results
should be communicated to the physician responsible for the
patient's care and documented.

III. Release.

At the time of release for infusion, a tag should be attached
to the container bearing information sufficient for
identification of the proper recipient and the component, and
clearly listing any relevant product testing. In addition,
information received after, during or as a result of the
processing procedure, including, but not limited to, type and
volume of any additive, method(s) of manipulation, and most
recent test results, should be included on the container tag or
packing slip.

Requests for copies of this publication may be
directed to:
Blood and Tissue Resources Program
New York State Department of Health
Wadsworth Center
Empire State Plaza
P.O. Box 509
Albany, New York 12201-0509
Telephone: (518) 485-5341
Fax: (518) 485-5342
E-mail: btraxess@health.state.ny.us.
Website:www.wadsworth.org/labcert/blood_tissue.